Surgical staples for internal use should be moved to a higher-risk category that scrutinizes them more intensely before they’re cleared for marketing, the FDA said in a proposed rule.
The agency proposes to reclassify the products from low risk to moderate risk medical devices with special controls. The reclassification would let the agency require premarket review and establish special controls for the staples, including obligatory performance testing and demonstration of usability.
The devices are currently not required to submit a premarket notification to the FDA before marketing. The agency said the reclassification is needed “based on new information.”